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    US, EU and Japan GMP Requirements: Practical ICH Area Differences, Healthcare Authority Inspection Focus

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    Website https://compliance2go.com/product/?pid=CP2014-382 | Want to Edit it Edit Freely

    Category Biotechnology , Medical Device , Pharmaceutical

    Deadline: November 10, 2014 | Date: November 10, 2014

    Venue/Country: Houston, U.S.A

    Updated: 2014-11-01 16:00:03 (GMT+9)

    Call For Papers - CFP

    DESCRIPTION

    This 90 minute webinar will help you gain a detailed overview of ICH GMPs and the nuances and differences between requirements in the US, EU and Japan. It will help prepare you for regulatory inspections in these countries.

    Why Should You Attend?

    This ICH GMP training course will provide your company the opportunity for a detailed overview of ICH GMP and the nuances and differences between the three main ICH triumvirate regions (U.S. EU and Japan).It will cover the key areas of how ICH was established, it's goals and objectives, expectations of the healthcare authorities involved and practical differences that you will experience in a GMP inspection of a facility by FDA, an EU Competent Authority or PMDA.

    Areas Covered in the Seminar :

    US, EU, Japan GMP Requirements(Practical ICH Area Differences, Healthcare Authority Inspection Focus)

    I . U.S., EU and Japan GMPs - Status of Harmonization and Where We're Heading

    Current efforts to further harmonize GMP requirements

    Future expectation & likely progress

    II . Where Inconsistencies Become a Problem: WHO, ICH, Countries

    Flexibility in global expectations

    Most challenging topics where alignment varies

    III . Key Chapter Reviews

    ICH GMP organization

    Category reviews

    IV . Compliance with ICH Guidelines for GMPs

    Understanding and Insight into Healthcare Authority expectations

    How GMP requirements / inspections can differ with a single ICH Standard

    How regulators (from 3 regions) will assess / enforce compliance with Q7

    V . GMP Comparisons for APIs

    Auditing API facilities

    Typical audit agenda

    ICH Area differences

    VI . GMP Comparisons for Finished Products

    Auditing finished product facilities

    Typical audit agenda

    ICH Area differences

    VII . GMP Comparisons for :

    Excipients

    Sterile products

    Biologics

    Clinical Packaging

    VIII . Differences on Area GMP Inspections

    Differences on how GMP inspections are conducted

    Areas of GMP inspection focus by area

    Modifying your self-inspection systems to customized area concerns

    IX . Outsourcing Management. A Regional Perspective on:

    Contract manufacturing

    Contract packaging.

    3 rd Party Contract testing

    X . Auditing Your Facilities for Global Considerations

    Importance of pre-audits to regional GMP focus.

    How to focus your internal audits to a US, EU and Japan compliance system.

    Who Will Benefit:

    This Webinar will provide valuable assistance to all License Owner personnel in the Pharmaceutical, Biotechnology and Combination Products areas, including contract manufacturers, packagers and suppliers. Particular functional expertise receiving value from attending would be:

    Manufacturing

    Quality Assurance

    Senior management

    Project Managers

    Qualified Persons (QPs)

    Regulatory Compliance

    CMC Personnel

    Packaging Experts

    Auditors and Staff

    Consultants

    Webinar Includes:

    Q/A Session with the Expert to ask your question

    Handouts (PDF print only copy of PowerPoint slides)

    90 Minutes Live Presentation

    Certificate of Attendance


    Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
    Disclaimer: ourGlocal is an open academical resource system, which anyone can edit or update. Usually, journal information updated by us, journal managers or others. So the information is old or wrong now. Specially, impact factor is changing every year. Even it was correct when updated, it may have been changed now. So please go to Thomson Reuters to confirm latest value about Journal impact factor.